Clinical Evaluation of Bonded Versus Banded Space Maintainers

NCT05087147 | Unknown DMC

• 1 other identifier: space maintainer
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparing bonded space maintainers to banded space maintainers

Conditions

Tooth Loss

Outcome Measures

Primary Outcomes (1)

• appliance failure

  Patient reported

  up to 12 months

Secondary Outcomes (1)

• Radiographic space loss

  up to 12 months

Study Arms (2)

Bonded space maintainer

EXPERIMENTAL

Wire bonded with composite to abutment teeth

Device: 0.7 mm stainless steel orthodontic wire

Banded space maintainer

ACTIVE COMPARATOR

Band and loop space maintainer

Device: Banded space maintainer

Interventions

0.7 mm stainless steel orthodontic wire DEVICE

0.7 mm stainless steel orthodontic wire

Bonded space maintainer

Banded space maintainer DEVICE

band and loop space maintainer

Banded space maintainer

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patient and parent showing cooperation and compliance. Medically free children. Patients having mandibular first deciduous molar indicated for extraction due to extensive coronal caries beyond possible repair, root caries and/or failed pulp therapy.
• Having all first permanent molars erupted and in Class I molar relation. According to space analysis available space is less than or equal to needed space.
• Having all their mandibular incisors erupted. With deciduous canines and second deciduous molars in the side of the extraction maintained throughout the entire follow-up period. Caries free, non-restored buccal surfaces of the mandibular second primary molars and deciduous canines. 1/3 to less than 2/3 of the root of the permanent successor is formed to the prematurely lost primary molars.

You may not qualify if:

• Children with any parafunctional habits. Children with previous allergies to stainless steel. Crowned abutment teeth. Permanent successors with 2/3 of its roots formed and space analysis does not indicate the fabrication of space maintainer.

Sponsors & Collaborators

• Omar Sherif Ahmed Abo El Abbas: lead

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Omar S Abo El Abbas

  Cairo U

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar S Abo El Abbas

CONTACT

0225196520; omar_aboelabbas0107@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statisticians
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 21, 2021
• Study Start: July 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share